Assessment of Self-Administration of Romiplostim in Patients with Immune Thrombocytopenic Purpura after Receipt of Home Administration Training Materials: a Cross-Sectional Study.

INTRODUCTION: Romiplostim is a subcutaneously administered thrombopoietin-receptor agonist approved in the European Union for self-administration (or administration by a caregiver) in selected adult patients with chronic primary immune thrombocytopenia refractory to other treatments. To mitigate the risk of medication errors due to self-administration, the manufacturer has implemented additional risk minimisation measures (RMM) in the form of a Home Administration Training (HAT) pack to support the training of both healthcare professionals (HCPs) (guide and checklist for patient selection and training) and patients (a preparation mat, quick guide booklet, step-by-step guide, self-administration diary and DVD/video). OBJECTIVE: The primary objective was to estimate the proportion of patients/caregivers who administered romiplostim correctly after HAT pack training. METHODS: A multicentre observational study was conducted to evaluate the effectiveness of the HAT pack by recording data on a standardised collection form during direct observation of patients/caregivers in the act of administering romiplostim at the first standard-of-care visit 4 weeks after training with the HAT pack. RESULTS: Among the 40 patients/caregivers enrolled across 12 study centres in eight European countries, 35 [87.5%; 95% confidence interval (CI) 73.9-94.5] administered romiplostim correctly, and five (12.5%; 95% CI 5.5-26.1) did not. CONCLUSION: The correct administration of romiplostim by most patients/caregivers supports the effectiveness of the HAT pack as an additional risk minimisation tool in the population and setting of this study.

Genital warts and cost of care in England.

OBJECTIVES: To estimate the total number of cases of, and cost of care for, genital warts (GWs) in England, to inform economic evaluations of human papillomavirus vaccination. METHODS: The number of GW cases seen in general practices (GPs) and in genitourinary medicine (GUM) clinics was estimated using the General Practice Research Database and the GUM Clinic Activity Dataset. The overlap in care of cases in the two settings was estimated. The calculated costs of care in GP and hospitals were added to the costs of care in GUM clinics (estimated elsewhere) to estimate the cost of care for GWs in England. RESULTS: In England, in 2008, GP and GUM saw 80,531 new (157/100,000 population) and 68,259 recurrent (133/100,000 population) episodes, giving a total of 148,790 episodes of care of GWs (289/100,000 population). Seventy-three per cent of cases were seen only in GUM clinics, 22% were seen by a GP before being referred to GUM, and 5% by GPs only. Hospital care was given in 1.3% of cases and contributed 8% of the costs. The average cost of care per episode was £113, and the estimated annual cost of care in England was £16.8 million. CONCLUSIONS: This study provides a fairly comprehensive measure of GW frequency and care in England. GWs exert a considerable impact on health services, a large proportion of which could be prevented through immunisation using the quadrivalent human papillomavirus vaccine.